IU Indianapolis ScholarWorks :: Browsing by Author "Burney, Heather N."

Browsing by Author "Burney, Heather N."

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A phase II study evaluating safety and efficacy of niraparib in patients with previously treated homologous recombination defective metastatic esophageal/gastroesophageal junction/proximal gastric adenocarcinoma
(Frontiers Media, 2024-11-21) Khalid, Ahmed Bilal; Fountzilas, Christos; Burney, Heather N.; Mamdani, Hirva; Schneider, Bryan P.; Fausel, Christopher; Perkins, Susan M.; Jalal, Shadia; Biostatistics and Health Data Science, Richard M. Fairbanks School of Public Health
Introduction: Esophageal adenocarcinoma (EAC) remains a devastating disease and second line treatment options in the metastatic space are limited. Homologous recombination (HR) defects have been described in EAC in up to 40% of patients. Poly (ADP-ribose) polymerase (PARP)1 and PARP2 inhibitors have shown efficacy in HR defective prostate and ovarian cancers. Here, we describe the activity of the PARP inhibitor niraparib in metastatic EAC with HR defects. Methods: In this single arm Simon two-stage Phase II study, we assessed the safety and efficacy of niraparib in patients with metastatic EAC previously treated with platinum containing chemotherapy harboring defective HR. Defective HR was defined as deleterious alterations in the following HR genes: BRCA1/2, PALB2, ATM, BARD1, BRIP1, CDK12, CHEK2, FANCA, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, NBN, ARID1A and GEN1. Results: 14 patients were enrolled in this study. The trial was stopped early due to slow accrual. 3 patients did not have post-treatment scans because of rapid clinical decline. The overall response rate (ORR) (95% exact CI) was 0/11 = 0% (0%, 28.49%). The disease control rate (DCR) (95% exact CI) was 2/11 = 18.2% (2.3%, 51.8%). The median PFS was 1.8 months (95% CI = 1.0-3.7). The median OS for evaluable patients was 6.6 months (95% CI =2.7-11.4) and 5.7 months for all patients (95% CI =2.7-10.1). The most common adverse events seen were anemia, fatigue, and thrombocytopenia. Conclusion: In patients with metastatic EAC, single agent niraparib as second line therapy is not an effective option.
A Phase II Trial of Adjuvant Durvalumab Following Trimodality Therapy for Locally Advanced Esophageal and Gastroesophageal Junction Adenocarcinoma: A Big Ten Cancer Research Consortium Study
(Frontiers Media, 2021-09-17) Mamdani, Hirva; Schneider, Bryan; Perkins, Susan M.; Burney, Heather N.; Kasi, Pashtoon Murtaza; Abushahin, Laith I.; Birdas, Thomas; Kesler, Kenneth; Watkins, Tracy M.; Badve, Sunil S.; Radovich, Milan; Jalal, Shadia I.; Surgery, School of Medicine
Background: Most patients with resectable locally advanced esophageal and gastroesophageal junction (GEJ) adenocarcinoma (AC) receive concurrent chemoradiation (CRT) followed by esophagectomy. The majority of patients do not achieve pathologic complete response (pCR) with neoadjuvant CRT, and the relapse rate is high among these patients. Methods: We conducted a phase II study (ClinicalTrials.gov Identifier: NCT02639065) evaluating the efficacy and safety of PD-L1 inhibitor durvalumab in patients with locally advanced esophageal and GEJ AC who have undergone neoadjuvant CRT followed by R0 resection with evidence of persistent residual disease in the surgical specimen. Patients received durvalumab 1500 mg IV every 4 weeks for up to 1 year. The primary endpoint was 1-year relapse free survival (RFS). Secondary endpoint was safety and tolerability of durvalumab following trimodality therapy. Exploratory endpoints included correlation of RFS with PD-L1 expression, HER-2 expression, and tumor immune cell population. Results: Thirty-seven patients were enrolled. The majority (64.9%) had pathologically positive lymph nodes. The most common treatment related adverse events were fatigue (27%), diarrhea (18.9%), arthralgia (16.2%), nausea (16.2%), pruritus (16.2%), cough (10.8%), and increase in AST/ALT/bilirubin (10.8%). Three (8.1%) patients developed grade 3 immune mediated adverse events. One-year RFS was 73% (95% CI, 56-84%) with median RFS of 21 months (95% CI, 14-40.4 months). Patients with GEJ AC had a trend toward superior 1-year RFS compared to those with esophageal AC (83% vs. 63%, p = 0.1534). There was a numerical trend toward superior 1-year RFS among patients with PD-L1 positive disease compared to those with PD-L1 negative disease, using CPS of ≥10 (100% vs. 66.7%, p = 0.1551) and ≥1 (84.2% vs. 61.1%, p = 0.1510) cutoffs. A higher relative proportion of M2 macrophages and CD4 memory activated T cells was associated with improved RFS (HR = 0.16; 95% CI, 0.05-0.59; p = 0.0053; and HR = 0.37; 95% CI, 0.15-0.93, p = 0.0351, respectively). Conclusions: Adjuvant durvalumab in patients with residual disease in the surgical specimen following trimodality therapy for locally advanced esophageal and GEJ AC led to clinically meaningful improvement in 1-year RFS compared to historical control rate. Higher PD-L1 expression may have a correlation with the efficacy of durvalumab in this setting. Higher proportion of M2 macrophages and CD4 memory activated T cells was associated with superior RFS.
Association of Heart Failure with Cognitive Decline and Development of Mild Cognitive Impairment and Dementia
(Wolters Kluwer, 2024) Jung, Miyeon; Apostolova, Liana G.; Gao, Sujuan; Burney, Heather N.; Lai, Dongbing; Saykin, Andrew J.; Pressler, Susan J.; School of Nursing
Background: Incidence of cognitive impairment and its consequences have not been fully examined in heart failure (HF). Objective: The aim of this study was to examine associations of HF with cognitive decline, frequencies and risks of, and time-to-develop mild cognitive impairment (MCI) or dementia during 15-year follow-up. Methods: For this retrospective cohort study, data were retrieved from the National Alzheimer's Coordinating Center. Cognitive decline was assessed using the Uniform Data Set neuropsychological battery. Development of MCI and dementia was assessed using clinically diagnosed cognitive status. Results: Compared with participants without HF (n = 12 904), participants with HF (n = 256) had more decline in attention, executive function, and memory while controlling for covariates including apolipoprotein E4. Participants with HF developed MCI or dementia more frequently (44.9% vs 34.4%), developed dementia faster from normal cognition, and had a lower risk of dementia from MCI after controlling for covariates (hazard ratio, 0.71) than participants without HF. Conclusions: Heart failure was associated with accelerated cognitive decline.
County-level correlates of completed HPV vaccination in Indiana
(Elsevier, 2023-09) Enujioke, Sharon C.; Shedd-Steele, Rivienne; Daggy, Joanne; Burney, Heather N.; Head, Katharine J.; Kasting, Monica L.; Zimet, Gregory; Communication Studies, School of Liberal Arts
The Healthy People 2030 goal is for 80% of all adolescents to complete their HPV vaccination series. Per the 2021, National Immunization Survey-Teen (NIS-Teen), 61.7% of adolescents have completed the series, and Indiana lags below the national average (55.2%). The present study estimated the 2-dose HPV vaccine series completion rates across Indiana counties among individuals aged 9–14 years who received their first dose of vaccine and determined what factors were associated with series completion at the county level. The association of county-level sociodemographic and health measures with series completion was also examined. Data were extracted from the Indiana Immunization Information System (IIS), administered by the Indiana Department of Health. All vaccine providers are required to report all immunizations to the system for any patient under age 19 years. All Indiana children ages 9–14 years at the time of first dose who had initiated HPV vaccination in 2017 or 2018 were included. Two-dose series completion was evaluated through October of 2020, allowing a minimum gap of 22 months from first dose administration. All statistical analyses were conducted at the county-level. The Indiana HPV vaccination series completion rate among individuals that received the first dose was on average 73% across counties, ranging from 55.7% to 90.4%. Higher series completion was positively associated with primary care providers per capita, participation in mammography screening among Medicare enrollees, median household income, life expectancy, percentage of residents with some college, percentage of adults up-to-date with colonoscopy screening, and percentage of adults with flu vaccine. There was wide variability in series completion across Indiana counties. HPV series completion was associated with county-level sociodemographic and health measures, particularly variables reflecting difficulties with access to care and lack of financial resources.
County-Level Factors Associated With Influenza and COVID-19 Vaccination in Indiana, 2020‒2022
(American Public Health Association, 2024) Kasting, Monica L.; Laily, Alfu; Burney, Heather N.; Head, Katharine J.; Daggy, Joanne K.; Zimet, Gregory D.; Schwab-Reese, Laura M.; Biostatistics and Health Data Science, Richard M. Fairbanks School of Public Health
Objectives: To assess COVID-19 and influenza vaccination rates across Indiana’s 92 counties and identify county-level factors associated with vaccination. Methods: We analyzed county-level data on adult COVID-19 vaccination from the Indiana vaccine registry and 2021 adult influenza vaccination from the Centers for Disease Control and Prevention. We used multiple linear regression (MLR) to determine county-level predictors of vaccinations. Results: COVID-19 vaccination ranged from 31.2% to 87.6% (mean = 58.0%); influenza vaccination ranged from 33.7% to 53.1% (mean = 42.9%). In MLR, COVID-19 vaccination was significantly associated with primary care providers per capita (b = 0.04; 95% confidence interval [CI] = 0.02, 0.05), median household income (b = 0.23; 95% CI = 0.12, 0.34), percentage Medicare enrollees with a mammogram (b = 0.29; 95% CI = 0.08, 0.51), percentage uninsured (b = −1.22; 95% CI = −1.57, −0.87), percentage African American (b = 0.31; 95% CI = 0.19, 0.42), percentage female (b = −0.97; 95% CI = −1.79, ‒0.15), and percentage who smoke (b = −0.75; 95% CI = −1.26, −0.23). Influenza vaccination was significantly associated with percentage uninsured (b = 0.71; 95% CI = 0.22, 1.21), percentage African American (b = −0.07; 95% CI = −0.13, −0.01), percentage Hispanic (b = −0.28; 95% CI = −0.40, −0.17), percentage who smoke (b = −0.85; 95% CI = −1.06, −0.64), and percentage who completed high school (b = 0.54; 95% CI = 0.21, 0.87). The MLR models explained 86.7% (COVID-19) and 70.2% (influenza) of the variance. Conclusions: Factors associated with COVID-19 and influenza vaccinations varied. Variables reflecting access to care (e.g., insurance) and higher risk of severe disease (e.g., smoking) are notable. Programs to improve access and target high-risk populations may improve vaccination rates.
Discovery of increased number or interval growth of brain metastases on same-day GammaKnife™ planning MRI: Predicting factors and patient outcomes
(Old City Publishing, 2022) Mereniuk, Todd R.; Burney, Heather N.; Lautenschlaeger, Tim; Watson, Gordon A.; Rhome, Ryan M.; Radiation Oncology, School of Medicine
Purpose: To determine factors associated with increased risk of finding new and/or enlarged brain metastases (BM) on GammaKnife™ (GK) MRI and their impact on patient outcomes. Results: 43.9% of patients showed BM growth, 32.9% had additional brain metastases (aBM), and 18.1 % had both. Initial brain metastasis velocity (iBMV) was associated with finding aBM. Time between diagnostic MRI (dMRI) and GK MRI was associated with interval growth and each day increased this risk by 2%. Prior brain metastasectomy and greater time between either dMRI or latest extracranial RT and GK MRI predicted both aBM and BM growth. aBM and/or BM growth led to management change in 1.8% of cases and were not associated with OS or incidence of distant intracranial failure. Conclusions: Number of metastases seen on dMRI and iBMV predicted both aBM and/or BM growth, however, these factors did not significantly affect survival or incidence of distant intracranial failure.
Epimeric vitamin D and cardiovascular structure and function in advanced CKD and after kidney transplantation
(Oxford University Press, 2024) Arroyo, Eliott; Leber, Cecilia A.; Burney, Heather N.; Li, Yang; Li, Xiaochun; Lu, Tzong-shi; Jones, Glenville; Kaufmann, Martin; Ting, Stephen M. S.; Hiemstra, Thomas F.; Zehnder, Daniel; Lim, Kenneth; Medicine, School of Medicine
Background: 25-hydroxyvitamin D can undergo C-3 epimerization to produce 3-epi-25(OH)D3. 3-epi-25(OH)D3 levels decline in chronic kidney disease (CKD), but its role in regulating the cardiovascular system is unknown. Herein, we examined the relationship between 3-epi-25(OH)D3, and cardiovascular functional and structural endpoints in patients with CKD. Methods: We examined n = 165 patients with advanced CKD from the Cardiopulmonary Exercise Testing in Renal Failure and After Kidney Transplantation (CAPER) study cohort, including those who underwent kidney transplant (KTR, n = 76) and waitlisted patients who did not (NTWC, n = 89). All patients underwent cardiopulmonary exercise testing and echocardiography at baseline, 2 months and 12 months. Serum 3-epi-25(OH)D3 was analyzed by liquid chromatography-tandem mass spectrometry. Results: Patients were stratified into quartiles of baseline 3-epi-25(OH)D3 (Q1: <0.4 ng/mL, n = 51; Q2: 0.4 ng/mL, n = 26; Q3: 0.5-0.7 ng/mL, n = 47; Q4: ≥0.8 ng/mL, n = 41). Patients in Q1 exhibited lower peak oxygen uptake [VO2Peak = 18.4 (16.2-20.8) mL/min/kg] compared with Q4 [20.8 (18.6-23.2) mL/min/kg; P = .009]. Linear mixed regression model showed that 3-epi-25(OH)D3 levels increased in KTR [from 0.47 (0.30) ng/mL to 0.90 (0.45) ng/mL] and declined in NTWC [from 0.61 (0.32) ng/mL to 0.45 (0.29) ng/mL; P < .001]. Serum 3-epi-25(OH)D3 was associated with VO2Peak longitudinally in both groups [KTR: β (standard error) = 2.53 (0.56), P < .001; NTWC: 2.73 (0.70), P < .001], but was not with left ventricular mass or arterial stiffness. Non-epimeric 25(OH)D3, 24,25(OH)2D3 and the 25(OH)D3:24,25(OH)2D3 ratio were not associated with any cardiovascular outcome (all P > .05). Conclusions: Changes in 3-epi-25(OH)D3 levels may regulate cardiovascular functional capacity in patients with advanced CKD.
FGF23 and Cardiovascular Structure and Function in Advanced Chronic Kidney Disease
(Wolters Kluwer, 2022-07-05) Halim, Arvin; Burney, Heather N.; Li, Xiaochun; Li, Yang; Tomkins, Claudia; Siedlecki, Andrew M.; Lu, Tzong-shi; Kalim, Sahir; Thadhani, Ravi; Moe, Sharon; Ting, Stephen M.S.; Zehnder, Daniel; Hiemstra, Thomas F.; Lim, Kenneth; Medicine, School of Medicine
Background: Fibroblast growth factor 23 (FGF23) is a bone-derived phosphatonin that is elevated in chronic kidney disease (CKD) and has been implicated in the development of cardiovascular disease. It is unknown whether elevated FGF23 in CKD is associated with impaired cardiovascular functional capacity, as assessed by maximum exercise oxygen consumption (VO2Max). We sought to determine whether FGF23 is associated with cardiovascular functional capacity in patients with advanced CKD and after improvement of VO2Max by kidney transplantation. Methods: We performed secondary analysis of 235 patients from the Cardiopulmonary Exercise Testing in Renal Failure and After Kidney Transplantation (CAPER) cohort, which recruited patients with stage 5 CKD who underwent kidney transplantation or were waitlisted and hypertensive controls. All patients underwent cardiopulmonary exercise testing (CPET) and echocardiography and were followed longitudinally for 1 year after study enrollment. Results: Patients across FGF23 quartiles differed in BMI (P=0.004) and mean arterial pressure (P<0.001) but did not significantly differ in sex (P=0.5) or age (P=0.08) compared with patients with lower levels of FGF23. Patients with higher FGF23 levels had impaired VO2Max (Q1: 24.2±4.8 ml/min per kilogram; Q4: 18.6±5.2 ml/min per kilogram; P<0.001), greater left ventricular mass index (LVMI; P<0.001), reduced HR at peak exercise (P<0.001), and maximal workload (P<0.001). Kidney transplantation conferred a significant decline in FGF23 at 2 months (P<0.001) before improvement in VO2Max at 1 year (P=0.008). Multivariable regression modeling revealed that changes in FGF23 was significantly associated with VO2Max in advanced CKD (P<0.001) and after improvement after kidney transplantation (P=0.006). FGF23 was associated with LVMI before kidney transplantation (P=0.003), however this association was lost after adjustment for dialysis status (P=0.4). FGF23 was not associated with LVMI after kidney transplantation in all models. Conclusions: FGF23 levels are associated with alterations in cardiovascular functional capacity in advanced CKD and after kidney transplantation. FGF23 is only associated with structural cardiac adaptations in advanced CKD but this was modified by dialysis status, and was not associated after kidney transplantation.
Incidence of Dementia and Alzheimer Disease Over Time: A Meta-Analysis
(Wiley, 2019-06-20) Gao, Sujuan; Burney, Heather N.; Callahan, Chris M.; Purnell, Christianna E.; Hendrie, Hugh C.; Biostatistics, School of Public Health
Background/Objectives: Population-based incidence estimates of dementia and Alzheimer’s disease (AD) provide important information for public health policy and resource allocation. We conducted a meta-analysis of published studies that reported age-specific incidence rates of dementia and AD to determine whether dementia and AD incidence rates are changing over time. Design: PubMed and MEDLINE were searched for publications through June 30, 2017 using keywords dementia, Alzheimer, and incidence. Inclusion criteria for the meta-analysis are: (1) population-based studies using personal interviews and direct examinations of the study subjects, (2) Standardized clinical diagnosis criteria, (3) Reporting age-specific incidence rates, (4) Published in English, and (5) Sample size greater or equal to 500 and length of follow-up greater or equal than two years. Mixed effects models were used to determine the association between birth year and incidence rates. Measurements: Age-specific dementia/AD incidence rates and their standard errors reported in each study. Results: Thirty-eight articles with 53 cohorts on dementia incidence and 31 articles with 35 cohorts on AD incidence met the inclusion criteria. There were significant associations between later birth years and decreased dementia incidence rates in all three age groups (65-74, 75-84 and 85+). There were no significant associations between birth year and AD incident rates in any of the three age groups. In particular, AD incidence rates reported from Western countries stayed steady in all age groups while studies in non-Western countries showed significantly increased AD incidence rates for the 65-74 age group (OR=2.78, p=0.04), but non-significant association for the 75-84 or 85+ groups. Conclusion: Dementia incidence declined over the last four decades, but AD incidence did not decline. Further research, especially from non-Western countries, is needed to elucidate the mechanism underlying the trends in dementia and AD incidence over time.
Initiation of Dialysis Is Associated With Impaired Cardiovascular Functional Capacity.
(AHA, 2022-07-19) Arroyo, Eliott; Umukoro, Peter E.; Burney, Heather N.; Li, Yang; Li, Xiaochun; Lane, Kathleen A.; Sher, S. Jawad; Lu, Tzong-Shi; Moe, Sharon M.; Moorthi, Ranjani; Coggan, Andrew R.; McGregor, Gordon; Hiemstra, Thomas F.; Zehnder, Daniel; Lim, Kenneth; Kinesiology, School of Health and Human Sciences
Background The transition to dialysis period carries a substantial increased cardiovascular risk in patients with chronic kidney disease. Despite this, alterations in cardiovascular functional capacity during this transition are largely unknown. The present study therefore sought to assess ventilatory exercise response measures in patients within 1 year of initiating dialysis. Methods and Results We conducted a cross-sectional study of 241 patients with chronic kidney disease stage 5 from the CAPER (Cardiopulmonary Exercise Testing in Renal Failure) study and from the intradialytic low-frequency electrical muscle stimulation pilot randomized controlled trial cohorts. Patients underwent cardiopulmonary exercise testing and echocardiography. Of the 241 patients (age, 48.9 [15.0] years; 154 [63.9%] men), 42 were predialytic (mean estimated glomerular filtration rate, 14 mL·min·1.73 m), 54 had a dialysis vintage ≤12 months, and 145 had a dialysis vintage >12 months. Dialysis vintage ≤12 months exhibited a significantly impaired cardiovascular functional capacity, as assessed by oxygen uptake at peak exercise (18.7 [5.8] mL·min·kg) compared with predialysis (22.7 [5.2] mL·min·kg; <0.001). Dialysis vintage ≤12 months also exhibited reduced peak workload, impaired peak heart rate, reduced circulatory power, and increased left ventricular mass index (<0.05 for all) compared with predialysis. After excluding those with prior kidney transplant, dialysis vintage >12 months exhibited a lower oxygen uptake at peak exercise (17.0 [4.9] mL·min·kg) compared with dialysis vintage ≤12 months (18.9 [5.9] mL·min·kg; =0.033). Conclusions Initiating dialysis is associated with a significant impairment in oxygen uptake at peak exercise and overall decrements in ventilatory and hemodynamic exercise responses that predispose patients to functional dependence. The magnitude of these changes is comparable to the differences between low-risk New York Heart Association class I and higher-risk New York Heart Association class II to IV heart failure.

Browsing by Author "Burney, Heather N."

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